Withdrawal of Cold Medicines: Addressing Parent Concerns

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In January 2008, the Food and Drug Administration (FDA) issued a public health advisory stating that children younger than 2 years should not be given cold medications because of serious and life-threatening side effects. The American Academy of Pediatrics (AAP) position is as follows:

Over-the-counter cough and cold medicines do not work for children younger than 6 years and in some cases may pose a health risk.

The efficacy and risk of such medications needs to be studied in children. As the AAP has testified: “If a medicine will be used in children, it should be studied in children. Cough and cold medications should not be exceptions to this rule.”

The labeling needs to reflect what we know—the medications are not effective for children younger than 6 years and their use, and misuse, could cause serious, adverse side effects.

When responding to concerned parents about treating their child, it is important to reassure parents that cold symptoms, while annoying and at times uncomfortable, are not dangerous and will go away in time. The following resources can be provided to parents to assist them in caring for their child:

The recommendations in this publication do not indicate an exclusive course of treatment or serve as a standard of medical care. Variations, taking into account individual circumstances, may be appropriate. This content is for informational purposes only. It is not intended to constitute financial or legal advice. A financial advisor or attorney should be consulted if financial or legal advice is desired.